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  1. Human Drug Exports

Current Good Manufacturing Practice Declarations

FDA issues letters, called current good manufacturing practice (CGMP) declarations, to foreign regulators that convey CGMP compliance status of establishments FDA has inspected.

Facilities located in the U.S. that have been included as part of a marketing application submitted to a foreign regulator request the letter from FDA. The agency then issues a letter directly to an identified foreign regulator conveying the CGMP compliance status for the facility within 30 days of receipt of the request.

A CGMP declaration should only be requested if a foreign regulator does not accept a valid certificate of pharmaceutical product (CPP) and wants additional assurance of a facility’s CGMP status.

CGMP declarations are one of several ways that FDA is enhancing communication and transparency with foreign regulatory authorities regarding the compliance status of establishments in the U.S. Foreign regulators also can find the CGMP status of an establishment by checking the FDA Data Dashboards for the most recent inspection classification.

An establishment may request a CGMP declaration using the agency’s online application process, CDER Export Certification Application and Tracking System (CDEReCATS), under the following conditions:

  1. An establishment can only request the CGMP status for its own site. Parent and affiliate companies may not request a declaration for an establishment.
  2. An establishment requesting a CGMP declaration must have the latest inspection conducted by the FDA as acceptable.
  3. A requesting establishment must have previously obtained a CPP prior to requesting a CGMP declaration or be able to provide a CPP number in which the establishment is included. This CPP does not need to be for the drug product for which the declaration is being sought but the CPP must be valid and not expired at the time of the declaration request.
  4. A request for a CGMP declaration can only be made using CDEReCATS. To access CDEReCATS, an establishment must have an FDA Industry System/FDA Unified Registration and Listing Systems (FURLS) account ID and password. Manufacturers that do not have a FURLS account may create a new account.
  5. A CGMP declaration application must include an email address for the foreign regulator. If the CGMP is issued, it will be sent directly to the foreign regulator’s email provided in the application.

These letters were part of FDA’s commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II), and as part of GDUFA III.

Contact
CDERexports@fda.hhs.gov

 
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